Oracle Health and Life Sciences (OHAI) is seeking an experienced leader to manage software development in a highly regulated environment, aiming to improve efficiency, reduce time-to-market, and ensure high-quality software delivery while maintaining compliance with evolving regulations.
Requirements
- Extensive experience in software development and delivery within regulated industries, preferably in healthcare or life sciences.
- In-depth understanding of medical device regulations, quality management systems, and software as a medical device (SaMD) concepts.
- Proficiency in process development and optimization, with a track record of implementing efficient software development methodologies.
Responsibilities
- Establish and maintain a robust software development framework, including centralized tools and standardized processes, to ensure compliance with regulatory requirements.
- Oversee the entire SDLC, from requirements gathering to post-market surveillance, ensuring all necessary documentation and evidence are maintained.
- Drive process improvements to increase development efficiency, reduce time-to-market, and ensure high-quality software delivery.
- Stay up-to-date with evolving regulations and industry trends, adapting processes to meet new standards.
- Manage and prioritize software releases, ensuring timely delivery to customers while maintaining compliance.
Other
- Lead and mentor a team of software professionals, providing technical and process-related guidance.
- Collaborate with cross-functional teams, including product management, quality assurance, and regulatory affairs, to define and implement best practices.
- Strong leadership skills and the ability to manage and motivate a diverse team.
- Excellent communication and collaboration skills, with the ability to work effectively across different teams and stakeholders.
- Ability to make strategic decisions and drive organizational change in a fast-paced environment.
